FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER
K Number: K851215
·
Decision Jun 18, 1985
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
7
Applicant Total
10
Review Days
84
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Basic Information
- Device Name
- T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER
- K Number
- K851215
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6885
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Penox Technologies, Inc.
- Date Received
- March 26, 1985
- Decision Date
- June 18, 1985
- Product Code
- CAM
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAM | Yoke Assembly, Medical Gas | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAM), ordered by most recent decision date.
YOKE ASSEMBLY MEDICAL GAS
FDA 510(k)
FDA Class 1
·Anesthesiology
PENOX DUAL FLOW MINIFOLD
FDA 510(k)
FDA Class 1
·Anesthesiology
PENOX DUAL FEED MANIFOLD
FDA 510(k)
FDA Class 1
·Anesthesiology
FILL HOSE SAFETY ADAPTER
FDA 510(k)
FDA Class 1
·Anesthesiology
GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB
FDA 510(k)
FDA Class 1
·Anesthesiology
OXYGEN/NITROUS OXIDE OUTLET
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Penox Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K864667 | PENOX HOSPITAL BED | Jan 21, 1987 | Substantially Equivalent |
| K863978 | PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) | Dec 15, 1986 | Substantially Equivalent |
| K862654 | MODIFIED PENOX LIFT CHAIR | Jul 18, 1986 | Substantially Equivalent |
| K853775 | PENOX HIGH FLOW MANIFOLD | Nov 29, 1985 | Substantially Equivalent |
| K852109 | PENOX PERFORMER WHEELCHAIR | Aug 22, 1985 | Substantially Equivalent |
| K851218 | PENOX LIFT CHAIR | Jun 21, 1985 | Substantially Equivalent |
| K851217 | PENOX DUAL FLOW MINIFOLD | Jun 18, 1985 | Substantially Equivalent |
| K851216 | PENOX DUAL FEED MANIFOLD | Jun 18, 1985 | Substantially Equivalent |
| K851219 | FILL HOSE SAFETY ADAPTER | Jun 18, 1985 | Substantially Equivalent |